WASHINGTON (BLOOMBERG) - The US Food and Drug Administration (FDA) said it's working toward rapid emergency-use authorisation of Pfizer's Covid-19 vaccine that was backed by a panel of agency advisers.
The drug regulator has "notified the US Centres for Disease Control and Prevention and Operation Warp Speed, so they can execute their plans for timely vaccine distribution," the FDA said Friday (Dec 11) in a statement.
The FDA statement comes as the agency is under tremendous political pressure from President Donald Trump and his administration to clear the vaccine, which has already been approved by the UK and Canada. Weary Americans are also eager for an end to a pandemic that has killed nearly 300,000 and dealt a crippling blow to the economy.
Mr Trump in a Friday tweet called the FDA "a big, old, slow turtle", and demanded that Dr Stephen Hahn, the agency's director, "get the dam vaccines out NOW."
Mr Alex Azar, the Health and Human Services Secretary, said in an interview with ABC that the FDA will soon clear the vaccine, and Americans may start getting shots as quickly as Monday. He tweeted that Pfizer has already been advised that the authorisation was coming.
Pfizer rose 1.7 per cent in trading before US markets opened. American depositary receipts of BioNTech, Pfizer's partner in developing the shot, gained 0.8 per cent.
On Thursday, an FDA advisory panel voted 17 to 4, with one abstention, in favour of authorising the vaccine, which was shown to be 95 per cent effective in a large clinical trial. While it often follows the panel's recommendations, the agency itself has final say in whether to grant the authorisation.
Part of the panel's discussion focused on whether there was enough data to support the vaccine's use in 16- and 17-year-olds, leaving some paediatricians on the advisory committee uncomfortable with voting in its favour. However, other members said data from older trial participants could be extrapolated to younger people.
A formal go-ahead from the FDA would set in motion a nationwide distribution effort, starting with 2.9 million doses being made available to states.
